AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days

Intervention: Drug: AL-46383A Ophthalmic Solution

Placebo Comparator: Vehicle

AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days

Intervention: Drug: AL-46383A Ophthalmic Solution Vehicle

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Terminated

Enrollment ICMJE

452

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.

Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.

Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).

Must agree to comply with the visit schedule and other requirements of the study.

Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Sub-epithelial infiltrates at the Day 1 visit in either eye.

Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.

Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.

Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.

Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.